In January 2022, the business kicked off a partnership with Olaris, a precision medicine company, to evaluate the feasibility of developing a diagnostic test to assess the risk of complications from overimmunosuppression in kidney transplant recipients. The test is designed to detect a metabolomics signature discovered via the Olaris platform.
Immunosuppressive treatment is required to prevent a recipient’s immune system from rejecting the organ. At times, this treatment can lead to overimmunosuppression and may leave patients susceptible to challenges like nerve damage due to infection.
Current diagnostic tools fail to assess this risk, and complications resulting from overimmunosuppression account for the second leading cause of death in transplant recipients within the first year. Together, Olaris and Thermo Fisher seek to address this need.
Soon, clinicians and kidney transplant recipients will be able to benefit from additional tests to support post-transplant monitoring and diagnosis of rejection. Thermo Fisher recently entered into an exclusive agreement with Bio-Techne Corporation to complete development of and commercialize the ExoTRU (Exosome Transplant Rejection Urine) assay, a non-invasive, multigene, urine-based exosomal mRNA test.
Today, the gold standard for assessing the health of a transplanted kidney relies on nonspecific measurements of kidney function, making treatment decisions difficult. Exosomes are small, extracellular vesicles that contain nucleic acids and proteins. These vesicles are derived from cells in the kidney graft, including lymphocytes that may have been invaded as part of an immune response against the organ. Because they are stable in urine, they may be useful for assessing kidney function.
The ExoTRU assay will be the first exosome-based test for rejection. Designed to potentially shed light on the cause of a rejection event, it may help clinicians optimize care, treatment and outcomes for kidney transplant recipients.
“In general, we are seeing a trend towards more reliable, noninvasive tools to ensure post-operative success of transplants, which is exciting,” said Dr. Chris Lawrence, Transplant Diagnostics Senior Director of Business Development and Medical Affairs.
The novel tests will complement Thermo Fisher’s existing portfolio for post-transplant monitoring, ensuring that laboratories and clinicians have a broad array of solutions for individualized patient management.
The One Lambda™ LABScreen™ assays for donor-specific antibodies are used by tissue-typing laboratories worldwide to monitor transplant recipients for risk of antibody-mediated rejection. MMDx® Kidney and MMDx® Heart tests use the GeneChip PrimeView Human Gene Expression Array from Thermo Fisher Scientific to measure transcript levels in biopsies, providing clinicians with objective insight into tissue damage.
All trademarks are the property of Thermo Fisher and its subsidiaries unless otherwise specified. MMDx is a registered trademark of Transcriptome Sciences Inc. ExoTRU is a registered trademark of Exosome Diagnostics, Inc. Not all products are CE marked or have 510(k) clearance for sale in the U.S. Availability of products in each country depends on local regulatory marketing authorization status.